High Accuracy HBsAb (Hepatitis B surface antibody ) Rapid Diagnostic test Cassette ,Infectious Disease Blood Tests

Intended Use:

The HBsAb Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies including IgG, IgM to Hepatitis B surface antigen (HBsAb) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Hepatitis B virus (HBV). Any reactive specimen with the HBsAb Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

Summary:

Hepatitis virus B (HBV) is the most common cause of persistent viremia and the most important cause of chronic liver disease and hepatocellular carcinoma. Clinically apparent HBV infections may have been extant for several millennia. It is estimated that there are 300 million chronic carriers of HBV in the world. The carrier rates vary from as little as 0.3% (Western countries) to 20% (Asia, Africa).

HBV is a hepatotropic DNA virus. The core of the virus contains a DNA polymerase, the core antigen (HBcAg) and the e antigen (HBeAg) . The core of HBV is enclosed in a coat that contains lipid, protein and carbohydrate and expresses an antigen terms hepatitis B surface antigen (HBsAg) 3.

HBsAg is the first marker to appear in the blood in acute hepatitis B, being detected 1 week to 2 months after exposure and 2 weeks to 2 months before the onset of symptoms. Simultaneous with or shortly after the disappearance of HBsAg, HBsAb is found in the blood. Its appearance heralds complete recovery, and its presence provides lifelong immunity.

The HBsAb Rapid Test detects HBsAb in serum or plasma in less than 15 minutes by untrained or minimally skilled personnel, without laboratory equipment.

TEST PRINCIPLE

The OnSite HBsAb Rapid Test is a lateral flow chromatographic immunoassay. The test strip consists of: 1) a burgundy colored conjugate pad containing HBsAg conjugated with colloid gold (HBsAg conjugates, 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with non-conjugated HBsAg, and the C band is pre-coated with goat anti-mouse IgG antibody.

When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. HBsAb if present in the specimen will bind to the HBsAg conjugates. The immunocomplex is then captured on the membrane by the pre-coated HBsAg, forming a burgundy colored T band, indicating a HBsAb positive test result.

Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat antimouse IgG/mouse IgG-gold conjugate regardless of the presence of colored T band. Otherwise, the test result is invalid and the specimen must be retested with another device.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

Performance

Sensitivity

The HBsAb One Step Hepatitis B Surface Antibody Test Strip (Serum/Plasma) has been tested with a sensitivity panel ranging from 1 mIU/mL to 40mIU/mL.The test can detect 10mIU/mL of HBsAb in 15minutes.

Specificity

Antigen used for the HBsAb One Step Hepatitis B Surface Antibody Test Strip (Serum/Plasma) is highly specific for detecting HBsAb in serum and plasma. The specificity was comparable to RIA.

Relative Sensitivity:>99.0%

Relative Specificity:98.7%

Accuracy:99.5%